Study of Novel Regimens in Relapsed or Refractory Multiple Myeloma

Study Purpose

This is a multicenter, open-label, phase I/II clinical study, to assess the safety, tolerability, antitumor activity, pharmacokinetics and pharmacodynamics of EOS884448 (also known as EOS-448 or GSK4428859A), alone or in combination with iberdomide with and without dexamethasone in participants with relapsed/refractory multiple myeloma (RRMM).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - All participants must have a documented diagnosis of relapse/refractory Multiple Myeloma and have measurable disease as defined per IMWG criteria.
  • - All participants must have received at least 3 prior lines of MM therapy with IMiD, PI and Anti-CD-38, and progressed on their last therapy (prior BCMA targeted therapy allowed).
  • - All participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0,1or 2.
  • - All participants must have adequate organ function.
  • - Females of childbearing potential (FCBP) or male participant must agree to follow contraception requirements.

Exclusion Criteria:

  • - All participants with non-secretory MM.
  • - All participants with known auto-immune disease.
  • - All participants with history of life-threatening toxicity related to prior immune therapy.
  • - All participants with active graft versus host disease after allogeneic stem cell transplantation.
  • - All participants with active, unstable cardiovascular function.
  • - All participants with active infection requiring systemic therapy.
  • - All participants with hypersensitivity to any of the treatments.
  • - All participants with any active gastrointestinal dysfunction that prevents the patient from swallowing tablets or interferes with absorption of study treatment.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05289492
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

iTeos Belgium SA
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Iteos Clinical Trials
Principal Investigator Affiliation iTeos Belgium SA
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Belgium, France, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Arms & Interventions

Arms

Experimental: A: Participants will receive EOS884448

EOS884448 will be administered

Experimental: B: Participants will receive EOS884448 and iberdomide

EOS884448 and iberdomide will be administered

Experimental: C: Participants will receive EOS884448, iberdomide and dexamethasone

EOS884448, iberdomide and dexamethasone will be administered

Interventions

Drug: - EOS884448

EOS884448 will be administered in arm A,B and C

Drug: - Iberdomide

Iberdomide will be administered in arm B and C

Drug: - Dexamethasone

Dexamethasone will be administered in arm C

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Banner MD Anderson, Gilbert, Arizona

Status

Recruiting

Address

Banner MD Anderson

Gilbert, Arizona, 85234

Site Contact

Clinical Trial Unit

clinical_info@iteostherapeutics.com

+3271919933

Norwich, Connecticut

Status

Recruiting

Address

Eastern Connecticut Hematology & Oncology

Norwich, Connecticut, 06360

Site Contact

Clinical Trial Unit

clinical_info@iteostherapeutics.com

+3271919933

Hackensack University Medical Center, Hackensack, New Jersey

Status

Recruiting

Address

Hackensack University Medical Center

Hackensack, New Jersey, 07601

Site Contact

David S. Siegel, MD, PhD

clinical_info@iteostherapeutics.com

+3271919933

Fred Hutchinson Cancer Center, Seattle, Washington

Status

Recruiting

Address

Fred Hutchinson Cancer Center

Seattle, Washington, 98109

Site Contact

Clinical Trial Unit

clinical_info@iteostherapeutics.com

+3271919933

International Sites

ZNA Cadix, Antwerp, Belgium

Status

Active, not recruiting

Address

ZNA Cadix

Antwerp, , 2020

Institut Jules Bordet, Brussels, Belgium

Status

Recruiting

Address

Institut Jules Bordet

Brussels, , 1070

Site Contact

Nathalie Meuleman, MD, PhD

clinical_info@iteostherapeutics.com

+3271919933

Universitaire Ziekenhuizen KU Leuven, Leuven, Belgium

Status

Recruiting

Address

Universitaire Ziekenhuizen KU Leuven

Leuven, , 3000

Site Contact

Michel Delforge, MD, Pr.

clinical_info@iteostherapeutics.com

+3271919933

CHU Amiens, Amiens, France

Status

Recruiting

Address

CHU Amiens

Amiens, , 80054

Site Contact

Clinical Trial Unit

clinical_info@iteostherapeutics.com

+3271919933

Nantes, France

Status

Recruiting

Address

Centre Hospitalier Universitaire de Nantes

Nantes, , 44093

Site Contact

Philippe Moreau, MD, Pr.

clinical_info@iteostherapeutics.com

+3271919933

APHP Hôpital Saint-Antoine, Paris, France

Status

Recruiting

Address

APHP Hôpital Saint-Antoine

Paris, , 75012

Site Contact

Clinical Trial Unit

clinical_info@iteostherapeutics.com

+3271919933

CHU de Poitiers, Poitiers, France

Status

Recruiting

Address

CHU de Poitiers

Poitiers, , 86021

Site Contact

Clinical Trial Unit

clinical_info@iteostherapeutics.com

+3271919933

CHU Toulouse, Toulouse, France

Status

Recruiting

Address

CHU Toulouse

Toulouse, , 31059

Site Contact

Clinical Trial Unit

clinical_info@iteostherapeutics.com

+3271919933

Hospital Fundacion Jimenez Diaz, Madrid, Spain

Status

Active, not recruiting

Address

Hospital Fundacion Jimenez Diaz

Madrid, , 28040